Kornimate/medical-research-clean huggingface dataset:
study of dehydroepiandrosterone (dhea) in respiratory pulmonary hypertension in adults

Conditions: Chronic Obstructive Pulmonary Disease; Hypertension, Pulmonary

Summary: dhea prevents and reverses chronic hypoxic pulmonary hypertension in a chronic hypoxic-pulmonary hypertension model in the rat. however, no study has been performed in human. the purpose of this study is to determine if dhea is effective in the treatment of respiratory pulmonary hypertension in adults with chronic obstructive pulmonary disease (copd) on exercise capacity and haemodynamic variables. patients will receive after randomisation either 25 mg/day or 200mg/day oral dhea over a one-year period. evaluation concerns clinical parameters, echocardiography and right catheterization after and before treatment. primary end-point is the six-minute walk test. this is a prospective double blind, randomised, placebo controlled study which will be realized in four university hospitals in france : bordeaux, strasbourg, toulouse and limoges.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old and ≤ 75 years old * chronic obstructive pulmonary disease with fevs/vc \< 70% (\*) * respiratory pulmonary hypertension with mean pulmonary arterial pressure ≥ 20 mmhg (\*) related to normal pulmonary capillar pressure assessed by catheterization of the right side of the heart (pulmonary capillary wedge pressure ≤12mmhg) * po2 ≤ 70 mmhg assessed by arterial gasometry at ease * if oxygenotherapy then oxygenotherapy more than 6 months before pre-screening * written informed consent (\*) criteria assessed from last health check or the last exams for copd diagnosis exclusion criteria: * clinical instability and/or respiratory exacerbation dangerous for catheterization * pregnancy (ßhcg \> 20 ui /l) or breastfeeding on going * general corticotherapy \> 0,5 mg/kg/day prednisolon equivalent * hepatic insufficiency (tp \ 130 µmol/l) or diabetes mellitus type i or ii (treated by oral antidiabetic or insulin) * left-heart failure (coronary heart disease and/or left valvulopathy) * high level of prostatic specific antigen (psa) (\> 7ng/ml) * cancer antecedent or treatment on going

Keywords: hypertension, pulmonary dhea six-minute walk test pulmonary arterial pressure
evaluation of the effect of sulphur mineral, thermal water on skin microbiome in plaque psoriasis, a pilot study

Conditions: Plaque Psoriasis

Summary: in this study the effects of balneotherapy in lake hévíz, 36℃ sulphur, carbonate, calcium, magnesium, hydrogen carbonate and very light radon-content thermal, mineral water on skin microbiome and psoriasis area and severity index (pasi) in patients with plaque psoriasis

psoriasis is a chronic inflammatory skin disease. it is associated with several important medical conditions, including psoriatic arthritis, and cardiometabolic syndrome. its most common form, chronic plaque.the aim of this study is to evaluate how lake hévíz sulphur thermal mineral water therapy influences the composition of microbial communities that colonizes skin in patients with psoriasis, and the extent and severity of skin symptoms of psoriasis. the planned participants number is 16 outpatients between 18 and 70 years of age with mild to moderate psoriasis. the balneotherapy takes place in lake hévíz, five times a week for three weeks. the skin microbiome is collected from two different place by swabbing method from the patient. one sample is collected from the normal skin, which is not affected by psoriasis (crook of the arm), the second sample is collected from psoriatic plaque of the elbow. the samples is processed for a sequence-based microbiome analysis. the skin microbiome is evaluated by the analysis of the sample metagenome compositions, and the activity of psoriasis is evaluated on the psoriasis area and severity index (pasi), is taken at week 0., at week 3.

Eligibility criteria:
inclusion criteria: * diagnosis of plaque psoriasis for at least 6 months before the baseline visit * subject has stable mild to moderate plaque psoriasis exclusion criteria: * subject has systemic therapy for plaque psoriasis * balneotherapy within 3 months prior the enrollement * systemic/local glucocorticoid therapy within 1 month prior the enrollment * general contraindications to balneotherapy: decompensated cardiovasculardisease; unstable hypertension, angina pectoris; uncontrolled endocrinedisease (hyperthyroidism, hyperparathyroidism); other uncontrolledand unstable metabolic disorders (diabetes mellitus, hyperuricaemia,hyperlipoproteinaemia); acute febrile infections; cutaneous suppuration;pregnancy; decompensated psychosis/neurosis, malignancy, urine and stool incontinent, unconsciousness, alcoholic influence, and lack of compliance.

Keywords: balneotherapy microbiome
adult height prediction in congenital adrenal hyperplasia

Conditions: Congenital Adrenal Hyperplasia

Summary: congenital adrenal hyperplasia (cah) is a genetic rare disease, which alters the adrenal production of gluco and mineralo corticoïds. the treatment consists in supplementing children with hydrocortisone. despite care for these children has improved substantially across decades, short adult height (ah) still remains an important consequence of the disease. about 20% of patients have an ah below 2 standard deviations compared to their expected ah. in the opale-model study, the investigators want to collect data from a cohort of 496 cah french patients, born between 1970 and 1991 with a known genotype. using their age, sex, growth, disease, bone maturation and pubertal data, the investigators will build a model which allows to predict their ah using data available at 8 years of age. the growth charts built from this cohort have shown that currently used formula to calculate the predicted ah (bayley-pineau's formula) is not applicable to children with cah. in this project, the investigators plan to compute an ah prediction model using data from children born between 1970 and 1993, and to validate the model using data from a different cohort (i.e. children born between 1994 and 1998). this choice was due to availability of data for computing the model first, and in a second stage, data from more recently born patients.


Eligibility criteria:
inclusion criteria: * children with cah, genetically proven, classical form, virilizing form, with deficit of 21 hydroxylase, 11 beta hydroxylase, or 3 beta ol dehydrogenase, born between 1972-1993 (cohort 1) and 1994-1998 (cohort 2). * medical charts should be available. exclusion criteria: * patients with chronic growth altering disease, turner syndrome, or other genetic anomaly * patients having received any treatment with growth hormone (gh)
rescue therapy for helicobacter pylori eradication treatment

Conditions: Helicobacter Pylori Infection

Summary: current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. however, tetracycline is clinically unavailable in china and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. this study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy in which tetracycline was replaced by minocycline.


Eligibility criteria:
inclusion criteria: * ability and willingness to participate in the study and to sign and give informed consent * confirmed h. pylori infection and with previous treatment failure exclusion criteria: * subjects naive to h. pylori treatment, * under 18 or over 80 years old * history of gastrectomy * pregnant or lactating women * severe systemic diseases or malignancy * administration of antibiotics, bismuth, antisecretory drugs, or chinese herb medicine in the preceding 8 weeks * contraindications to the study drugs

Keywords: helicobacter pylori rescue therapy minocycline tetracycline
procedure selection in obesity and metabolic surgery based on eoss

Conditions: Postoperative Complications

Summary: the edmonton obesity staging system (eoss) is a more comprehensive measure of obesity-related diseases and predictor of mortality than bmi or waist circumference. eoss is also important in predicting post - operative outcome and 30-day mortality after metabolic surgery. the aim of this study is to determine whether eoss could be an indicator for procedure selection in obesity and metabolic surgery.

all patients in germany, who underwent sleeve gastrectomy, roux-en y gastric bypass and mini/one anastomosis gastric bypass as a primary procedure for severe obesity, are prospectively registered in the german register studoq mbe. preoperative eoss by sharma et al. will be applied to all patients, who were operated between februar 2015 and july 2017 by two different evaluators. data collection will include the following: gender, age, body mass index, mobility, comorbidities, asa score (american society of anesthesiologists score) perioperative complications next to clavien dindo, readmission rates and 30 - day mortality. follow-up will be investigated in all patients up to 1 month after surgery. complications, readmission rates and 30 day mortality will be investigated in relation to eoss and the surgical procedure performed, to determine whether eoss could be an indicator for procedure selection in obesity and metabolic surgery.

Eligibility criteria:
inclusion criteria: sleeve for severe obesity rnygb for severe obesity mgb/oagb for severe obesity - exclusion criteria: * previous obesity surgery * previous surgery of the upper gastrointestinal tract in anamnesis

Keywords: eoss obesity and metabolic surgery postoperative outcome procedure selection
dupilumab for the treatment of moderate to severe chronic hepatic pruritus

Conditions: Pruritus

Summary: to investigate the potential efficacy of dupilumab in the treatment of moderate to severe chronic hepatic pruritus.

this is a 22-week (2 week screening, 18-week treatment period followed by a 2 week followup), phase ii, open label, exploratory study to investigate the potential efficacy of fda approved dupilumab in the treatment of adults with moderate to severe chronic hepatic pruritus. subjects will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this trial. once consent has been obtained, baseline values will be established and subjects will begin treatment and follow-up for the next 20 weeks. a final visit will be needed for evaluation and questionnaire completion.

Eligibility criteria:
inclusion criteria: * male and/or female subjects 18 years or older with chronic pruritus of moderate to severe severity in the setting of intrahepatic or extrahepatic cholestatic liver disease. chronic is defined as greater than 6 weeks of symptom duration. pruritus severity is based on the peak pruritus numerical rating score of ≥ 4 (moderate severity). * documentation of a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial. * willingness and ability to comply with scheduled clinic visits, physical exams, laboratory tests, questionnaires, and other trial procedures. exclusion criteria: * male and/or female subjects under 18 years of age. * pruritus due to a primary inflammatory skin dermatosis or other forms of psychogenic pruritus utilizing skin biopsies as needed. * pregnant females * history of intrahepatic cholestasis of pregnancy * any form of chronic hepatic pruritus associated with underlying malignancy * liver transplant recipients * allergy to dupilumab or its ingredients * inability to provide informed consent * concomitant use of selective opioid antagonists * subjects with severe asthma (requiring high-dose inhaled or systemic corticosteroids) will be excluded from the study. * patients with known helminth infections

Keywords: dupilumab
using emg of the healthy hand to control tens of the affected hand in hemiparetic patients

Conditions: Stroke

Summary: the purpose of this study is to investigate learning transfer from the healthy hand to the paretic hand in stroke patients. emg signals from the healthy hand - while performing wrist dorsi flexion movement - will be used to activate electric muscles stimulation of the dorsi flexors of the paretic hand.

14 post-stroke subjects will be recruited from neurological rehabilitation department at loewenstein rehabilitation hospital, ra'anana, israel. the patients will be randomly assigned to one of two groups: 1) experimental group. 2) control group. the 3 weeks intervention (15 sessions) in each group will include electric muscles stimuli (pulse rate 35-100hz pulse width 200 microseconds, 5 sec on and 10 sec rest ) of the hemiparetic hand for 15 minutes. the patients in the experimental group will wear a wireless bluetooth emg ("myo" bracelet) on their healthy forearm and when they will execute wrist dorsi flexion, the data will be transmitted to a pc which will be used to activate (via arduino controller) a transcutaneous electric nerve stimulator (tens) that is attached to the paretic dorsi flexors (electrodes are placed on the paretic forearm). the control group will get only automatic stimuli on the paretic forearm via the tens. the assessments will be done before the intervention, at the end of three weeks of intervention, and after 1 month from the end of the intervention (follow up). the outcomes will include: active range of motion of fingers and wrist dorsi flexion (using cybermin 5dt glove for digital measures), upper limb section of fugl-meyer test, box and blocks test and jebsen taylor hand function test. only before the beginning of the intervention the sensory ability of the patient will be assessed using the sensory section of fugl-meyer (fm) and semmes-weinstein filaments for superficial sensation. normalized lesion data will be computed using the able module within medx software (medical numerics). differences between groups will be calculated using t-tests or mann-whitney, depending on distribution of normality with corrections for multiple comparisons.

Eligibility criteria:
inclusion criteria: * first stroke * age 25-80 years * able to understand research instructions exclusion criteria: * unstable clinical/metabolic state

Keywords: cross education emg
assessment of strem-1 as a diagnostic marker in patients with neutropenic fever

Conditions: Neutropenic Fever

Summary: the soluble triggering receptor expressed on myeloid cells-1 (strem-1) was an established biomarker useful for infection in non-neutropenic patients. in this study, we tested strem-1 in the patients with neutropenic fever. pro-calcitonin (pct) and c-reactive protein (crp) were also measured. we planned to investigate and explore the role of strem-1 in early diagnosis of infection in patients with neutropenic fever.

patients with hematological malignancies developed neutropenia after chemotherapy. we checked the serum level of strem-1 in patients with neutropenic fever. those patients were classified to 2 groups: documented infection or low likelihood of infection. their strem-1 level was measured and was compared with other biomarker such as crp and procalcitonin. the value of strem-1 for diagnosis of infection in patients with neutropenic fever was thus evaluated.

Eligibility criteria:
inclusion criteria: * chemotherapy-related neutropenia (granulocytes \ 38.0°c over a 6 hour observation period or body temperature ≥ 38.5°c once. exclusion criteria: * prolonged fever before presenting for admission, * antibiotics therapy in the past 72 hours, * more than two sites of infectious focus, * concomitant solid organ malignancy and blast in hemogram.
risk factors predicting serious complications with laparoscopic gastric bypass surgery

Conditions: Postoperative Complications

Summary: the rate of serious complications are relatively low in bariatric surgery today, but still 3-4 % will suffer from a serious complication. there are factors known before the surgery or during the operation that are likely to increase the risk for a serious complication. if the investigators are aware of these we can optimize the patients risk factors prior to the operation or at least increase the awareness of the increased risk in some patients given the presence of risk factors.

data is collected prospectively to the scandinavian obesity surgery registry. today all 44 clinics performing bariatric surgery in sweden submits data on baseline characteristics, operational data and data from a 30 days, 1 year, 2 years and 5 years follow up for all patients. the database is compared annually to the swedish civil registry to cover all mortality. from the database we will identify patients who underwent a bariatric procedure between may 1st 2007 and september 30th 2012. patients undergoing other bariatric procedures than laparoscopic gastric bypass or revisional surgery will be excluded. the data will be analyzed with "chi-2" test, logarithmic regression, linear regression or t-test when appropriate. odds ratio will be calculated.

Eligibility criteria:
inclusion criteria: undergoing laparoscopic gastric bypass surgery and included in the scandinavian obesity surgery registry exclusion criteria: undergoing other bariatric procedure than laparoscopic gastric bypass. revisional surgery is excluded. lost to follow up.

Keywords: bariatric surgery postoperative complications
the effect of choline alfoscerate on improvement of cognitive function in elderly patients with diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: in this study, the investigators are going to investigate the efficacy of choline alfoscerate on improvement of cognitive function assessed by mmse compared to plaebo.

the investigators will enroll patients with type 2 diabetes whose age is equal to higher than 60, and randomly assigned study drug or placebo at 1:1 ratio. the treatment duration is 6 months and extension study will be continued to 12 months.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * baseline mmse score 25-28 exclusion criteria: * type 1 diabetes * diabetes ketoacidosis or hyperosmolar hyperglycemic crisis * hba1c over than 9.0% * mmse less than 25 * abnormal tsh levels * vitamin b12 deficiency * severe infection, perioperative state, trauma * hypopituitarism or adrenal insufficiency * any conditions that lead to hospitalization * chronic alcoholics within 1 year * any drugs that can influence to cognitive function within 3 months
daily aspirin vs split dosing in high-risk pregnancies (dash)

Conditions: Preterm Birth; Preeclampsia

Summary: aspirin is recommended in high risk patients to reduce the risk of preeclampsia and preterm birth, which are leading causes of both maternal and neonatal morbidity and mortality, but up to 20% will have these adverse outcomes despite therapy. gaps in knowledge regarding pregnancy specific aspirin pharmacology and the relationship of aspirin response and pregnancy outcome, along with a lack of consensus on aspirin dosing has limited the effective use of this intervention. the investigators aim to apply principles of clinical pharmacology to determine how to optimally utilize this low cost medication to improve maternal/child health outcomes. this is a phase i/ii randomized controlled trial of high risk pregnancies recommended aspirin; participants will be randomized to take aspirin either 162mg once daily, or 81mg twice a day. outcomes evaluated will include the difference in aspirin response between these two dosing regimens, the individual factors that impact aspirin pharmacology in pregnancy, and evaluate markers or aspirin response that may be associated with pregnancy outcome.

this is an unblinded randomized controlled phase i/ii trial comparing high risk singleton pregnancies randomized to 162mg daily (daily dose) vs 81mg q12hours (split dose). participants will be enrolled prior to 16 weeks gestation. the primary outcome is platelet inhibition as assessed by pfa-100 epinephrine closure time, assessed 2-4 weeks after initiation and again at 28-32 weeks gestation. a subset of participants will be enrolled in a pharmacokinetic study to evaluate pharmacokinetics of aspirin in pregnancy at the two dosing intervals. secondary outcomes include urine thromboxane at each visit, platelet associated micrornas. individual factors associated with aspirin pharmacokinetics and pharmacodynamics in pregnancy will be assessed. finally, the relationship between these pharmacodynamic markers and pregnancy outcome will be evaluated.

Eligibility criteria:
inclusion criteria * singleton gestation gestational age \<16 0/7 weeks, dating confirmed with ultrasound * ≥1 high risk factor for preeclampsia or ≥2 moderate risk factors as per united states preventative services task force (2021) * recommendation for 162mg aspirin daily in pregnancy * age 16-55 years old exclusion criteria * contraindication to aspirin * current or planned use of any other anticoagulation * thrombocytopenia, other known platelet or bleeding disorder * abnormally elevated baseline pfa-100 epinephrine closure time prior to aspirin initiation

Keywords: aspirin preeclampsia preterm birth pregnancy pharmacokinetics pharmacodynamics phase i/ii randomized clinical trial